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Simethicone 80 mg Tablet, Chewable, 4-count — NDC 71610-0607-04 package photo

Simethicone 80 mg Tablet, Chewable, 4-count

by Aphena Pharma Solutions - Tennessee, LLC · 4 TABLET, CHEWABLE in 1 BOTTLE (71610-607-04)
NDC 71610-0607-04
🏷️ FDA NDC (as labeled) 71610-607-04 billing pads the product segment with a zero
This package
Contains4-count Pack sizes2 compare ↓
Also comes in: 2 tablets 71610-0607-02
OTC On market Non-controlled
🗂️ Data synced Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 71610-607-04
Product NDC 71610-607
11-digit billing NDC 71610060704
NCPDP billing unit EA — each (per item)
RxCUI 314216
UNII 92RU3N3Y1O
Application # M002
SPL Set ID da0cc98e-1692-405a-ab81-420d6f9df6de
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-03-01
Route ORAL
Dosage form TABLET, CHEWABLE
Substance DIMETHICONE
GCN Seq No 002821
GCN 08281
HICL code 001224
Ingredient (HICL) Simethicone
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4N
Therapeutic class — specific (HIC3) Antiflatulents
AHFS code 56:10.00.00
AHFS class Antiflatulents
FDB label name SIMETHICONE 80 MG TAB CHEW
FDB brand name Simethicone
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 71610-607-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71610-0607-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerAphena Pharma Solutions - Tennessee, LLC
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code71610
First marketedMar 2011
Product typeHuman Otc Drug
Portfolio795 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name SIMETHICONE 80 MG TAB CHEW Ingredient Simethicone
📖 What it is MedlinePlus · NLM

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Simethicone works to relieve the uncomfortable pressure, bloating, and full or stuffed feeling that comes from trapped gas in your stomach or intestines. It's used when gas builds...
  • What exactly does simethicone do for gas?
  • Yes — there are infant-specific simethicone products, like Mylicon Infants Gas Relief and similar infant drops, designed just for babies. They're used to relieve gas discomfort tha...
  • Can I give simethicone drops to my baby?
📖 Read our full Simethicone guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeRound
ImprintAP;019
Size13 mm
ScoringNot scored
FlavorPeppermint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII IY9XDZ35W2
    Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII V95R5KMY2B
    Peppermint is a flavoring agent derived from the peppermint plant. It's added to medicines to improve taste and mask bitter or unpleasant flavors, making them easier to take.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

6 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesdextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 2 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Antiflatulent 80 mg 00904-7206-60 Major 100 tablets $0.032 — Availability likely —
GNP Regular Strength Gas Relief 80 mg 24385-0118-78 Amerisource 100 tablets $0.032 — Availability likely —
Leader Gas relief 80 mg 70000-0434-01 CARDINAL 100 tablets $0.032 — Availability likely —
Gas Relief 80 mg 70677-1067-01 STRATEGIC 36 tablets $0.032 — Availability likely —
Gas Relief 80 mg 17714-0019-01 Advance 100 tablets — — FDA listed —
GNP Regular Strength Gas Relief 80 mg 17856-1118-01 ATLANTIC 1 tablet — — FDA listed —
CVS PHARMACY Gas relief 80 mg 51316-0111-00 CVS 100 tablets — — FDA listed —
Gas relief Anti-gas 80 mg 51316-0904-16 CVS 100 tablets — — FDA listed —
Gas relief 80 mg 53041-0103-16 Guardian 100 tablets — — FDA listed —
Gas relief 80 mg 53943-0301-16 Discount 100 tablets — — FDA listed —
Simethicone 80 mg 54738-0518-01 Richmond 100 tablets — — FDA listed —
Simethicone 80Mg 80 mg 55154-2606-00 Cardinal 1 tablet — — FDA listed —
Simethicone 80 mg 57896-0791-01 Geri-Care 100 tablets — — FDA listed —
QC Gas Relief Mint Flavor 80 mg 63868-0108-01 QUALITY 100 tablets — — FDA listed —
Simethicone 80 mg 68071-2746-03 NuCare 30 tablets — — FDA listed —
Gas Relief Mint Flavor 80 mg 68163-0111-36 Raritan 36 tablets — — FDA listed —
Simethicone 80 mg 69618-0033-01 Reliable 100 tablets — — FDA listed —
Simethicone 80 mgthis 71610-0607-04 Aphena 4 tablets — — FDA listed —
Simethicone 80 mg 71610-0649-04 Aphena 4 tablets — — FDA listed —
Antiflatulent 80 mg 71610-0650-04 Aphena 4 tablets — — FDA listed —
Simethicone 80Mg 80 mg 77333-0812-10 Gendose 1 tablet — — FDA listed —
Simethicone 80 mg 82804-0043-30 Proficient 30 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2011
On the market since
Mar 2011
📍
2026
Currently FDA-listed
15 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Simethicone — the ingredient across all brands.

Top reported reactions

Chronic Kidney Disease1,159
Nausea723
Diarrhoea673
Fatigue644
Acute Kidney Injury633
Renal Failure583
Pain416

Reporter sex

8,245 reports

Serious outcomes

Death769
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 961 236
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71610-0607-04 You're viewing this 4 TABLET, CHEWABLE in 1 BOTTLE (71610-607-04) 2021-10-25 Active
71610-0607-02 2 TABLET, CHEWABLE in 1 BOTTLE (71610-607-02) 2026-07-28 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71610-0607-04?
NDC 71610-0607-04 is a 4-count package — 4 tablet, chewable in 1 bottle.
What is the difference between NDC 71610-0607-04 and NDC 71610-0607-02?
Both are Simethicone 80 mg Tablet, Chewable — the drug itself is identical. NDC 71610-0607-04 is the 4-count package, while NDC 71610-0607-02 is the 2 tablets package.
What NDC number is used to bill for this package of Simethicone 80 mg Tablet, Chewable?
Bill NDC 71610-0607-04 — the 11-digit billing format is 71610060704. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71610-607-04, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71610-0607-04, written without dashes as 71610060704. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71610-0607-04, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0607) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 2 tablets (71610-0607-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 17 words ▾

Uses relieves bloating pressure discomfort of gas which can be caused by certain foods or air swallowing

⏱️ Dosage and Administration 27 words ▾

Directions chew thoroughly 1 to 2 tablets as needed after meals and at bed time. do not exceed 6 tablets per day unless directed by a doctor

⚠️ Warnings 11 words ▾

Warnings If pregnant or breast-feeding, ask a health professional before use.

🧪 Active Ingredient 9 words ▾

Active Ingredient (in each chewable tablet) Simethicone 80 mg

🧪 Inactive Ingredients 11 words ▾

Inactive Ingredients dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid

🎯 Purpose 2 words ▾

Purpose Antiflatulent

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71610-0606-17 · Aphena 71610-0608-60 · Aphena →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.